High-risk Patients in Cardiac Surgery Procedures: HiriSCORE (HiriSCORE)

An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

• To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures
• Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.

Study Overview

• Status: Unknown
• Conditions: C.Surgical Procedure; Cardiac

Detailed Description

The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures.

Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

• To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II> 5 or STS-score> 5);
• Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures.

It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II.

The study will include the patients of 18 years old or older who have undergone cardiac surgery procedures, such as coronary artery bypass grafting (isolated or combined with any heart valve intervention), heart valve surgery, and surgery on the ascending aorta (only combined with operations on the aortic valve or CABG).

Totally, it is proposed assessment of 170 variables (factors perceived risk) for each patient (preoperative, intraoperative, and up to 12 hours after surgery).

The study of mortality and postoperative complications such as renal replacement therapy, stroke, reoperation for bleeding, respiratory failure, cardiogenic shock, will be carried out within 30 days after cardiac surgery procedures.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05409011
    • Recruiting
    • Fabio B Jatene, MD, PhD
    • Contact: Omar AV Mejia, MD PhD; Phone Number: 11-996862043; Email: omarvmejia@gmail.com
    • Contact: Maxim Dmitrievich Goncharov, MD; Phone Number: 11-976816107; Email: goncharovmaxim86@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery procedures

Description

Inclusion Criteria:

• Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes
• Mortality risk with STS score>5 or EuroSCORE II>5

Exclusion Criteria:

• Isolated surgery on ascending aorta, aortic arch or descending aorta
• Heart transplantation
• Impossibility to include patient´s data in research

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Development / 2000 participants; Age >18 years;; Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5.
Validation / 1000 participants; Age >18 years;; Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality analysis	Patient´s mortality data collection following 30 days after the main procedure	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke with neurological consequences (pareses or plegia)	Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure	30 days
ST-elevation Myocardial infarction	ST- elevation Myocardial infarction following 30 days after the main procedure	30 days
Non- ST- elevation Myocardial infarction	Non- ST- elevation Myocardial infarction following 30 days after the main procedure	30 days
Deep sternal wound infection	Deep sternal wound infection following 30 days after the main procedure	30 days
Bleeding requiring reoperation	Bleeding requiring reoperation following 30 days after the main procedure	30 days
Sepsis	Sepsis following 30 days after the main procedure	30 days
Endocarditis	Endocarditis following 30 days after the main procedure	30 days
Respiratory failure	Respiratory failure following 30 days after the main procedure	30 days
Renal replacement therapy	Renal replacement therapy following 30 days after the main procedure	30 days
Hepatic failure	Hepatic failure following 30 days after the main procedure	30 days
Unplanned cardiac reoperation	Unplanned cardiac reoperation following 30 days after the main procedure	30 days
Unplanned cardiac percutaneous intervention	Unplanned cardiac percutaneous intervention following 30 days after the main procedure	30 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: InCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência Portuguesa de São Paulo; Hospital de Base; National Institute of Cardiology, Laranjeiras, Brazil; Cardiology Institute of the Distrito Federal, Brazil; Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil; Russian Cardiology Research and Production Center, Russia; TotalCor Hospital, Brazil; Dante Pazzanese Institute of Cardiology, Brazil; Santa Casa de Misericórdia of Marília, Brazil; Novosibirsk Cardiology Recearch and Production Center, Russia
• Investigators: Study Chair: Fábio B Jatene, MD, PhD, Heart Institute of São Paulo Medical School; Study Director: Omar AV Mejía, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Maxim D Goncharov, MD, Heart Institute of São Paulo Medical School; Principal Investigator: Camila PS Arthur, MD, Heart Institute of São Paulo Medical School; Principal Investigator: Ricardo R Dias, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Carlos MA Brandão, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Rodrigo C Segalote, MD, National Cardiology Institute; Principal Investigator: Diego M Ferreira, MD, National Cardiology Institute; Principal Investigator: Marcos G Tiveron, MD, PhD, Santa Casa de Misericórdia of Marília; Principal Investigator: Helton A Bomfim, N, Santa Casa de Misericórdia of Marília; Principal Investigator: Renat Suleimanovich Akchurin, MD, PhD, Russian Cardiology Research and Production Center; Principal Investigator: Elina Evgenievna Vlasova, MD, Russian Cardiology Research and Production Center; Principal Investigator: Pedro Gabriel M de Barros e Silva, MD, PhD, TotalCor Hospital; Principal Investigator: João Galantier, MD, TotalCor Hospital; Principal Investigator: Alexandre C Hueb, MD,PhD, Clinical Hospital Samuel Libânio of Pouso Alegre; Principal Investigator: Maurício LJ Guerrieri, MD, Clinical Hospital Samuel Libânio of Pouso Alegre; Principal Investigator: Marcelo A Nakazone, MD, PhD, Hospital de Base of São José de Rio Preto; Principal Investigator: Mauricio N Machado, MD, PhD, Hospital de Base of São José de Rio Preto; Principal Investigator: Fernando A Atik, MD, PhD, Cardiology Institute of the Distrito Federal; Principal Investigator: Murilo T Macedo, MD, Cardiology Institute of the Distrito Federal; Principal Investigator: Luís RP Dallan, MD, Heart Institute of São Paulo Medical School; Principal Investigator: José AD Santiago, MD, Heart Institute of São Paulo Medical School; Principal Investigator: Elinthon T Veronese, MD, Heart Institute of São Paulo Medical School; Principal Investigator: Pablo MA Pomerantzeff, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Luiz Augusto F Lisboa, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Luís Alberto O Dallan, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Shengshou Hu, MD, PhD, Fuwai Hospital and Cardiovascular Institute; Principal Investigator: Zhe Zheng, MD, PhD, Fuwai Hospital and Cardiovascular Institute; Principal Investigator: Heng Zhang, MD, PhD, Fuwai Hospital and Cardiovascular Institute; Principal Investigator: Alexander Bogachev-Prokofiev, MD, PhD, Novosibirsk Cardiology Recearch and Production Complex; Principal Investigator: Magaly Arrais dos Santos, MD, PhD, Instituto Dante Pazzanese de Cardiologia; Principal Investigator: Jenny Rivas de Oliveira, MD, Instituto Dante Pazzanese de Cardiologia; Principal Investigator: Luiz C Bento de Souza, MD, PhD, Instituto Dante Pazzanese de Cardiologia; Principal Investigator: Jóse H Palma da Fonseca, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Filomena Regina BG Galas, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Ludhmila A Hajjar, MD, PhD, Heart Institute of São Paulo Medical School; Principal Investigator: Roberto Kalil Filho, MD, PhD, Heart Institute of São Paulo Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Morbidity; Mortality; Risk assessment; Risk factor
• Other Study ID Numbers: USaoPauloGH1001; 1.289.986 (Other Identifier: Ethics Committee for the Analysis of Research Projects)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data can be used by centers coparticipants after approval by the HiriSCORE group.